Effects of Transcranial Magnetic Stimulation (TMS) and Cognitive Training for Alzheimer Patients

Testing the Effects of TMS Stimulation and Cognitive Training for Alzheimer Patients: A Pilot Study

Sponsors

Lead Sponsor: Assaf-Harofeh Medical Center

Source Assaf-Harofeh Medical Center
Brief Summary

Current diagnosis of Alzheimer disease is made by clinical, neuropsychological, and neuroimaging assessments. Routine structural neuroimaging evaluation is based on nonspecific features, such as atrophy, which is a late feature in the progression of the disease. Therefore, developing new approaches for early and specific recognition of Alzheimer disease at the prodromal stages is of crucial importance.

In the present study the investigators would like to examine if combined treatment with TMS and cognitive training (CoTra) for several weeks can produce a sustained improvement in cognitive and behavioral symptomatology of Alzheimer's disease (AD) patients. A number of in vivo neuroimaging techniques, which can be used to reliably and noninvasively assess aspects of neuroanatomy, chemistry, physiology, and pathology, hold promise.

Overall Status Completed
Start Date July 2009
Completion Date July 2010
Primary Completion Date July 2010
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Evaluation of the efficacy of the TMS stimulation with cognitive training in treatment of early- to mid- stage Alzheimer's patients will be established by improvement of at least 4 points on ADAS-COG. 3 months
Secondary Outcome
Measure Time Frame
Safety will be established by paucity of related adverse events. 3 months
Enrollment 20
Condition
Intervention

Intervention Type: Device

Intervention Name: TMS stimulation

Description: TMS stimulation and cognitive training

Arm Group Label: Treatment Group (#1)

Intervention Type: Device

Intervention Name: Sham comparator

Description: Sham comparator

Arm Group Label: Control group (#2)

Intervention Type: Behavioral

Intervention Name: Cognitive training

Description: TMS stimulation and cognitive training

Arm Group Label: Treatment Group (#1)

Eligibility

Criteria:

Inclusion Criteria:

- Male or female age 55-85 years

- Patients diagnosed with early or moderate stage of Alzheimer's disease, according to the DSM-IV criteria.

- MMSE score 15 to 26

- Global Dementia rating 1 or 2

- Physically acceptable for the study as confirmed by medical history and exam, clinical laboratory results and EKG

- Spouse, family member or professional caregiver agree and capable of taking care and responsibility for the participation of the patient in the study (transportation for the patient to and from the investigator's clinic, answering questions regarding the patient's condition and assuming responsibility for medication)

- Written informed consent by patient or legally responsible caregiver.

- Able to undergo MRI scanning sessions (e.g., prior to the onset of the study, upon the attainment of the primary end-point and at the end of the study).

- Commitment to participation in six-to eighteen weeks of the trial regimen consisting of approximately1 hour TMS stimulation and cognitive training daily treatment of five days a week - six to eighteen weeks (and up to two treatments a day in case the Third TMS stimulation and cognitive training Treatment protocol if necessary).

Exclusion Criteria:

- Severe agitation;

- Mental retardation;

- Unstable medical condition;

- Use of benzodiazepines or other hypnotics during the study and preceding two weeks;

- Pharmacological immunosuppression;

- Participation in a clinical trial with any investigational agent within two weeks prior to study enrollment;

- Alcoholism;

- History of Epileptic Seizures or Epilepsy;

- Contraindication for performing MRI scanning;

- Clinically significant abnormal laboratory findings which have not been approved by the Project Director;

Gender: All

Minimum Age: 55 Years

Maximum Age: 85 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Shai Efrati, MD Principal Investigator Assaf-Harofeh MC
Location
Facility: Assaf-Harofeh MC
Location Countries

Israel

Verification Date

July 2010

Responsible Party

Name Title: Dr. Shai Efrati

Organization: Assaf Harofeh Medical center

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Treatment Group (#1)

Type: Experimental

Label: Control group (#2)

Type: Sham Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

Source: ClinicalTrials.gov